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Trial record 65 of 298 for:    "Ankylosing spondylitis"

Comparative Evaluation of Pharmacokinetics and Safety of BCD-055 and Remicade in Patients With Ankylosing Spondylitis

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ClinicalTrials.gov Identifier: NCT02359903
Recruitment Status : Completed
First Posted : February 10, 2015
Results First Posted : June 8, 2016
Last Update Posted : June 8, 2016
Sponsor:
Information provided by (Responsible Party):
Biocad

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Ankylosing Spondylitis
Interventions Drug: Infliximab (BCD-055)
Drug: Infliximab (Remicade)
Enrollment 90
Recruitment Details  
Pre-assignment Details  
Arm/Group Title BCD-055 Group Remicade Group
Hide Arm/Group Description

BCD-055 (infliximab) at a dose of 5 mg/kg, administered as a slow intravenous infusion, which will be performed on week 0, 2, 6, 14 and 22

Infliximab (BCD-055): infliximab is a chimeric monoclonal antibody against tumor necrosis factor alpha

Remicade (infliximab) at a dose of 5 mg/kg, administered as a slow intravenous infusion, which will be performed on week 0, 2, 6, 14 and 22

Infliximab (Remicade)

Period Title: Overall Study
Started 45 45
Completed 45 43
Not Completed 0 2
Reason Not Completed
Adverse Event             0             2
Arm/Group Title BCD-055 Group Remicade Group Total
Hide Arm/Group Description

BCD-055 (infliximab) at a dose of 5 mg/kg, administered as a slow intravenous infusion, which will be performed on week 0, 2, 6, 14 and 22

Infliximab (BCD-055): infliximab is a chimeric monoclonal antibody against tumor necrosis factor alpha

Remicade (infliximab) at a dose of 5 mg/kg, administered as a slow intravenous infusion, which will be performed on week 0, 2, 6, 14 and 22

Infliximab (Remicade)

Total of all reporting groups
Overall Number of Baseline Participants 45 45 90
Hide Baseline Analysis Population Description
All patients who received at least 1 injection of study drug
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 45 participants 45 participants 90 participants
38
(32 to 51)
38
(35 to 55)
38
(33 to 53)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants 45 participants 90 participants
Female
12
  26.7%
14
  31.1%
26
  28.9%
Male
33
  73.3%
31
  68.9%
64
  71.1%
1.Primary Outcome
Title Area Under the Plasma Concentration-time Curve From Zero (0) Hours to 336 Hours After the Single Infusion of BCD-055/Remicade
Hide Description [Not Specified]
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who received at least 1 injection. From BCD-055 group 1 patient was excluded because of violation of timing of blood collection. From Remicade group 2 patients were excluded due to AE/SAE.
Arm/Group Title BCD-055 Group Remicade Group
Hide Arm/Group Description:

BCD-055 (infliximab) at a dose of 5 mg/kg, administered as a slow intravenous infusion, which will be performed on week 0, 2, 6, 14 and 22

Infliximab (BCD-055): infliximab is a chimeric monoclonal antibody against tumor necrosis factor alpha

Remicade (infliximab) at a dose of 5 mg/kg, administered as a slow intravenous infusion, which will be performed on week 0, 2, 6, 14 and 22

Infliximab (Remicade)

Overall Number of Participants Analyzed 44 43
Median (Inter-Quartile Range)
Unit of Measure: (ng/ml)*hour
26282582
(21094742 to 32296361)
25914888
(20105020 to 32661812)
2.Secondary Outcome
Title Maximum Concentration of Infliximab After the Single Infusion of BCD-055/Remicade
Hide Description Patients who received at least 1 injection. From BCD-055 group 1 patient was excluded because of violation of timing of blood collection. From Remicade group 2 patients were excluded due to AE/SAE.
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title BCD-055 Group Remicade Group
Hide Arm/Group Description:

BCD-055 (infliximab) at a dose of 5 mg/kg, administered as a slow intravenous infusion, which will be performed on week 0, 2, 6, 14 and 22

Infliximab (BCD-055): infliximab is a chimeric monoclonal antibody against tumor necrosis factor alpha

Remicade (infliximab) at a dose of 5 mg/kg, administered as a slow intravenous infusion, which will be performed on week 0, 2, 6, 14 and 22

Infliximab (Remicade)

Overall Number of Participants Analyzed 44 43
Median (Inter-Quartile Range)
Unit of Measure: ng/ml
174638
(139415 to 239141)
195434
(134622 to 257656)
3.Secondary Outcome
Title Time of Maximum Concentration of Infliximab After the Single Infusion of BCD-055/Remicade
Hide Description [Not Specified]
Time Frame 2 weeks
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Maximum Concentration of Infliximab After the 1st, 2nd, 3rd, 4th and 5th Infusion of BCD-055/Remicade
Hide Description [Not Specified]
Time Frame 28 weeks
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Minimum Concentration of Infliximab After the 1st, 2nd, 3rd, 4th and 5th Infusion of BCD-055/Remicade
Hide Description [Not Specified]
Time Frame 28 weeks
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Time of Maximum Concentration of Infliximab After the1st, 2nd, 3rd, 4th and 5th Infusion of BCD-055/Remicade
Hide Description [Not Specified]
Time Frame 28 weeks
Outcome Measure Data Not Reported
7.Secondary Outcome
Title Half Life of Infliximab After the 1st and 5th Infusion of BCD-055/Remicade
Hide Description [Not Specified]
Time Frame 2 weeks / 28 weeks
Outcome Measure Data Not Reported
8.Secondary Outcome
Title Average Concentration of Infliximab at Steady State Phase
Hide Description [Not Specified]
Time Frame 28 weeks
Outcome Measure Data Not Reported
9.Secondary Outcome
Title Percentage of Patients in Each Group Achieving ASAS20
Hide Description [Not Specified]
Time Frame 14 weeks / 30 weeks
Outcome Measure Data Not Reported
10.Secondary Outcome
Title Percentage of Patients in Each Group Achieving ASAS40
Hide Description [Not Specified]
Time Frame 14 weeks / 30 weeks
Outcome Measure Data Not Reported
11.Secondary Outcome
Title Mean Change of BASDAI Score Compared With Baseline
Hide Description [Not Specified]
Time Frame 14 weeks / 30 weeks
Outcome Measure Data Not Reported
12.Secondary Outcome
Title Mean Change of BASMI Score Compared With Baseline
Hide Description [Not Specified]
Time Frame 14 weeks / 30 weeks
Outcome Measure Data Not Reported
13.Secondary Outcome
Title Mean Change of BASFI Score Compared With Baseline
Hide Description [Not Specified]
Time Frame 14 weeks / 30 weeks
Outcome Measure Data Not Reported
14.Secondary Outcome
Title Mean Change of MASES Score Compared With Baseline
Hide Description [Not Specified]
Time Frame 14 weeks / 30 weeks
Outcome Measure Data Not Reported
15.Secondary Outcome
Title Mean Change of SF36 Score Compared With Baseline
Hide Description [Not Specified]
Time Frame 14 weeks / 30 weeks
Outcome Measure Data Not Reported
16.Secondary Outcome
Title Mean Change of Chest Expansion Compared With Baseline
Hide Description [Not Specified]
Time Frame 14 weeks / 30 weeks
Outcome Measure Data Not Reported
17.Secondary Outcome
Title Frequency of AE/SAE After the Single Infusion of BCD-055/Remicade
Hide Description [Not Specified]
Time Frame 2 weeks
Outcome Measure Data Not Reported
18.Secondary Outcome
Title Total Frequency of AE/SAE Within the Whole Time of the Study
Hide Description [Not Specified]
Time Frame 30 weeks
Outcome Measure Data Not Reported
19.Secondary Outcome
Title Total Frequency of Grade 3-4 Laboratory Abnormalities Within the Whole Time of the Study
Hide Description [Not Specified]
Time Frame 30 weeks
Outcome Measure Data Not Reported
20.Secondary Outcome
Title Percentage of Patients in Whom Bind or Neutralizing Antibodies to Infliximab Were Detected
Hide Description [Not Specified]
Time Frame screening / 14 weeks / 30 weeks
Outcome Measure Data Not Reported
21.Secondary Outcome
Title Frequency of Early Withdrawal Due to AE/SAE
Hide Description [Not Specified]
Time Frame 30 weeks
Outcome Measure Data Not Reported
22.Other Pre-specified Outcome
Title Maximum Concentration at Steady State
Hide Description [Not Specified]
Time Frame 28 weeks
Outcome Measure Data Not Reported
23.Other Pre-specified Outcome
Title Area Under the Plasma Concentration-time Curve at Steady State Phase
Hide Description [Not Specified]
Time Frame 28 weeks
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title BCD-055 Group Remicade Group
Hide Arm/Group Description

BCD-055 (infliximab) at a dose of 5 mg/kg, administered as a slow intravenous infusion, which will be performed on week 0, 2, 6, 14 and 22

Infliximab (BCD-055): infliximab is a chimeric monoclonal antibody against tumor necrosis factor alpha

Remicade (infliximab) at a dose of 5 mg/kg, administered as a slow intravenous infusion, which will be performed on week 0, 2, 6, 14 and 22

Infliximab (Remicade)

All-Cause Mortality
BCD-055 Group Remicade Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
BCD-055 Group Remicade Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/45 (0.00%)   1/45 (2.22%) 
Vascular disorders     
Collapse   0/45 (0.00%)  1/45 (2.22%) 
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
BCD-055 Group Remicade Group
Affected / at Risk (%) Affected / at Risk (%)
Total   4/45 (8.89%)   4/45 (8.89%) 
Blood and lymphatic system disorders     
Arterial hypertension   4/45 (8.89%)  4/45 (8.89%) 
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Biryulin Andrey
Organization: BIOCAD
Phone: +7812380 49 33 ext 925
Responsible Party: Biocad
ClinicalTrials.gov Identifier: NCT02359903     History of Changes
Other Study ID Numbers: BCD-055-1/ASART-1
First Submitted: January 30, 2015
First Posted: February 10, 2015
Results First Submitted: April 3, 2016
Results First Posted: June 8, 2016
Last Update Posted: June 8, 2016